Delivery System with Pacing Element

ABSTRACT

Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient&#39;s heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

BACKGROUND

Often patients have a problem with their heart beating at a regular andappropriate pace. Many patients require a pacemaker or similar device toaid in pacing their heart. Further, certain patients require heart valverepair or a prosthetic heart valve implant to help with related orseparate problems from these pacing issues. During medical procedures,such as a trans-catheter aortic valve implant (TAVI) procedure,physicians may want to pace the heart. In other instances physicians maydesire to pace the patient's heart following these or other procedures.

In some instances pacing of a patient's heart may be required after aprevious procedure, such as implanting a prosthetic heart valve. Thusthere is a need to help with pacing of the heart during such repair orimplant procedures as well as after such procedures. There is a need toeliminate multiple procedures and to simplify the process. There is aneed for a delivery system or apparatus for delivering a biocompatiblematerial and to prevent or correct pacing problems.

BRIEF SUMMARY

In accordance with some embodiments, a delivery system comprises apacing element. This pacing element may be disposed on the tip of thedelivery system. This pacing element may also be disposed on a portionof a prosthesis, such as a prosthetic heart valve. This pacing elementmay be included on a portion of the frame as a strip or a coating ofhighly conductive material. This pacing element may comprise animplantable pacemaker. This implantable pacemaker may be disposed on aportion of a catheter-based delivery system. The implantable pacemakermay be configured to be attached to a portion of a patient's heart, suchas a ventricle.

Some embodiments disclose a medical device delivery assembly, theassembly comprising a catheter-based delivery system having anelectrical pacing element at a tip region of the catheter-based deliverysystem. In some embodiments the delivery system is configured to receivea biocompatible material.

In some embodiments the biocompatible material comprises a prosthesis.

In some embodiments the prosthesis comprises a prosthetic heart valve.In some embodiments the pacing element comprises an implantablepacemaker.

In some embodiments the implantable pacemaker is configured to pace theheart during a procedure to implant the prosthetic heart valve. In someembodiments the implantable pacemaker is configured to contact aventricle of the heart.

In some embodiments the implantable pacemaker is configured to pace theheart after a procedure to implant the prosthetic heart valve.

In some embodiments the electrical pacing element is configured to pacethe heart during a heart valve repair procedure.

In some embodiments the catheter-based delivery system further comprisesa lumen. In some embodiments the pacing element is configured to permita delivery system element to pass thru the pacing element.

In some embodiments the pacing element comprises an electrode disposedproximate an end of the delivery system. In some embodiments theelectrode is configured to receive and transmit electric current andcontact the heart to provide pacing for at least a portion of time whenthe delivery system is present in the heart.

Some embodiments include a method for providing a medical device andpacing a heart, the method comprising introducing an assembly into aheart. In some embodiments the assembly comprises a delivery systemhaving proximal and distal ends and includes an inner sheath and anouter sheath, a biocompatible material disposed on the inner sheath in acollapsed state and configured to expand to an expanded state. In someembodiments a pacing element can be positioned proximate a tip region ofthe delivery system.

In some embodiments the method comprises pacing the heart. In someembodiments the method may include retracting the outer sheath,implanting the biocompatible material, and removing the delivery systemfrom the heart.

In some embodiments the biocompatible material comprises a prostheticheart valve. In some embodiments pacing the heart comprises contacting apacing element including an electrode to a wall of a ventricle beforeexpanding the heart valve and providing electrical current to theelectrode. In some embodiments pacing the heart ends prior to removingthe delivery system from the heart.

In some embodiments the method comprises detaching the pacing elementfrom the assembly and contacting the pacing element to a ventricle ofthe heart. In some embodiments pacing the heart occurs after removingthe delivery system from the heart.

In some embodiments the prosthetic heart valve further comprises a valveassembly and a frame. In some embodiments pacing the heart comprisesusing the prosthetic heart valve with a conductive portion of the framesuch that the conductive portion paces the heart.

In some embodiments the prosthetic heart valve further comprises a valveassembly and a frame. In some embodiments pacing the heart comprisesusing the prosthetic heart valve with conductive portions of the framesuch that the conductive portions pace the heart.

In some embodiments the prosthetic heart valve further comprises aninsulative portion of the frame.

In some embodiments pacing the heart further comprises contacting animplantable pacemaker to a ventricle and providing electrical current tothe heart via the implantable pacemaker. In some embodiments pacing theheart continues after removing the delivery system from the heart.

In some embodiments the heart valve comprises a valve assembly, a frame,and a pacing strip.

In some embodiments the pacing strip comprises a conductive sectionattached to the frame of the heart valve to improve electricalcommunication in the heart.

In some embodiments the frame of the heart valve further comprises aninsulated section to impede electrical communication in the heart.

In some embodiments the frame of the heart valve further comprisesmultiple insulated sections or multiple conductive sections.

In some embodiments an assembly for introduction into a heart isdisclosed, the assembly comprising a delivery system having proximal anddistal portions, a heart valve configured to collapse and expand, and animplantable pacemaker.

In some embodiments the delivery system comprises an inner sheath and anouter sheath. In some embodiments the inner sheath and outer sheath areconfigured to be retractable. In some embodiments wherein the heartvalve is disposed on the inner sheath in a collapsed state. In someembodiments wherein the implantable pacemaker is disposed on the distalportion of the delivery system. In some embodiments the implantablepacemaker is configured to electrically pace the heart during and afterimplantation of the heart valve. In some embodiments the implantablepacemaker is configured to contact a ventricle of a heart and separatefrom the delivery system.

The embodiments and related concepts will be more fully understood fromthe following detailed description of the embodiments thereof.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A-1E illustrate a delivery system in accordance with someembodiments;

FIGS. 2A-2B illustrate a delivery system in accordance with someembodiments;

FIGS. 3A-3D illustrate a delivery system in accordance with someembodiments;

FIGS. 4A-4C illustrate a delivery system in accordance with someembodiments; and

FIGS. 5-9 illustrate a prosthetic heart valve in accordance with someembodiments.

DETAILED DESCRIPTION OF EMBODIMENTS

While the disclosure refers to illustrative embodiments for particularembodiments, it should be understood that the disclosure is not limitedthereto. Modifications can be made to the embodiments described hereinwithout departing from the spirit and scope of the present disclosure.Those skilled in the art with access to this disclosure will recognizeadditional modifications, embodiments, and embodiments within the scopeof this disclosure and additional fields, in which the disclosedexamples could be applied. Therefore, the following detailed descriptionis not meant to be limiting. Further, it is understood that theapparatus and methods described below can be implemented in manydifferent embodiments of hardware. Any actual hardware described is notmeant to be limiting. The operation and behavior of the apparatus andmethods presented are described with the understanding thatmodifications and variations of the embodiments are possible.

References to “one embodiment,” “an embodiment,” “some embodiments,” “incertain embodiments,” etc . . . , indicate that the embodiment describedmay include a particular feature, structure, or characteristic, butevery embodiment may not necessarily include the particular feature,structure, or characteristic. Moreover, such phrases are not necessarilyreferring to the same embodiment. Further, when a particular feature,structure, or characteristic is described in connection with anembodiment, it is submitted that it is within the knowledge of oneskilled in the art to affect such feature, structure, or characteristicin connection with other embodiments whether or not explicitlydescribed.

An apparatus is disclosed to help with pacing of a patient's heartduring or after a procedure on the patient. Incorporating a pacingelement on to the delivery system simplifies the process of pacing theheart during a procedure and eliminates the need for a second procedurein some instances.

Sometimes while the physician performs a valve repair or prostheticheart valve implantation, the physician may determine the need foraddition pacing following the procedure. In some instances the physicianmay implant a pacing element during the same procedure rather thanperforming a second procedure to correct heart pacing problems. In otherinstances the physician may use a pacing element as a preventativemeasure. Using such a pacing element may be precautionary and preventfuture heart pacing problems.

In some embodiments a delivery system is disclosed in which a TAVI isincluded as well as a pacing element. This pacing element may beincorporated directly onto a biocompatible material. Or this pacingelement may be incorporated onto a secondary element disposed on adelivery system. This pacing element can help with pacing of a patient'sheart before, during, and after a procedure. In some embodiments thepacing element may be an implantable pacing element.

In some embodiments the pacing element may be incorporated onto abiocompatible material itself. In some embodiments the biocompatiblematerial may comprise a prosthesis or a prosthetic heart valve. In someembodiments a prosthetic heart valve may incorporate a highly conductivestrip as part of the frame of the prosthetic heart valve frame.

This highly conductive strip or strips may facilitate communication nearthe atrioventricular (AV) node and may help the heart to functionnormally during or after implantation of a prosthetic heart valve. Insome embodiments the conductive strip is configured to be positionedproximate a native heart valve. In some embodiments the conductive stripmay be positioned proximate the sinoatrial node. The conductive stripmay also facilitate communication near a different node or portion of apatient's heart. This strip may alternatively improve communication toany portion of the heart. This can prevent the need for a pacemaker tobe implanted following the procedure with a biocompatible material or aprosthetic heart valve. In some embodiments the conductive strips may becomprised of a material with conductivity greater than nitinol or steel.One example may be silver or silver alloy. In some embodiments theconductive strips may be comprised of a biocompatible material. Theconductive strip material may be configured such that the prostheticheart valve may be configured to self-expand. The conductive stripmaterial may be comprised of a material with sufficient elasticity toprevent chipping, cracking, or other problems when the material expands.

In some embodiments the conductive strips may create a new conductivepathway that may allow the AV node to function correctly after theprosthetic heart valve is implanted. This frame with conductive stripsor portions may create a new conductive pathway for cardiac conductivesignals or prevent the current conductive pathways from being affectedby a biocompatible material, such a prosthetic heart valve. This mayreduce the number of pacemaker implants required after treatment with abiocompatible material or prosthetic heart valve.

In some embodiments a portion of a prosthetic heart valve may include acoating. This coating may be a conductive coating or an insulativecoating. This coating may be an alternative to a strip being attached tothe frame of a prosthetic heart valve. In some embodiments theprosthetic heart valve may include both a conductive coating and aninsulative coding. The insulative coating may prevent the prostheticheart valve frame from interfering with the AV node's conductivepathway, and may it prevent the need to implant a pacemaker followingdeployment of a prosthetic heart valve. The disclosed apparatus may beused for pacing on either side of the heart. For example the apparatusmay be used for pacing of the right atrioventricular valve or the leftatrioventricular valve. It is contemplated that this apparatus can beused and adapted for multiple areas of the human heart, includingmultiple valve areas. In some embodiments the insulative strips may becomprised of a material with insulative properties greater than nitinolor steel. In some embodiments the insulative strips may be comprised ofa biocompatible material. In some embodiments the insulative strips maybe configured so that the prosthetic heart valve may be self-expanding.The insulative strip material may be comprised of a material withsufficient elasticity to prevent chipping, cracking, or other problemswhen the material expands.

Coating the frame with conductive or insulative coatings may preventdisturbance of the natural conductive pathways of the heart. Insulativecoating of the frame may prevent radial conduction of the frame disposedinside the heart. This will prevent interruptions in the conductivepathways of the human heart.

In some embodiments the delivery system comprises a delivery assembly.The delivery assembly may comprise a catheter-based delivery system.This catheter-based delivery system may include an electrical pacingelement. In some embodiments the electrical pacing element may bedisposed at a tip region of the catheter-based delivery system. In someembodiments the delivery system is configured to receive a biocompatiblematerial. This biocompatible material may be of many types. In someembodiments this biocompatible material may be a material used for heartvalve repair on either side of a human heart. In some embodiments thisbiocompatible material may comprise a prosthesis or a device. In someembodiments this biocompatible material may comprise a prosthetic heartvalve to be implanted in a patient. In some embodiments thisbiocompatible material may be another type of material to be received ina patient.

In some embodiments an electrical pacing element is included as anelement of the delivery system. In some embodiments the pacing elementcomprises an implantable pacemaker. In some embodiments this implantablepacemaker is included as part of the delivery system in a combinedfashion. In some embodiments the pacing element may include a portion ofa biocompatible material and may be a prosthetic heart valve.

In some embodiments the pacing element may be an electrode disposedproximate the tip of the delivery system. This electrode may include apower source disposed on the delivery system or may include a powersource separate from the delivery system. In some embodiments the pacingelement is configured to pace the heart during or after a procedure onthe patient's heart. This procedure may include a procedure to implant aprosthetic heart valve or valve repair.

In some embodiments an implantable pacemaker is configured to attach toa ventricle of the heart. In some embodiments the implantable pacemakermay be configured to be attached to a ventricle of the heart during thesame procedure in which a prosthetic heart valve is implanted in thepatient. In some embodiments the implantable pacemaker may be configuredto be attached to a ventricle of the heart during the same procedure asa heart valve repair.

In some embodiments the implantable pacemaker is configured to pace theheart before, during, or after a procedure to implant a biocompatiblematerial, such as a prosthetic heart valve. In some embodiments theimplantable pacemaker is configured to pace the heart during and after aprocedure on the heart. This procedure on the heart may include a valverepair procedure or a prosthetic heart valve implant procedure, amongothers.

In some embodiments the delivery system may comprise a guide lumen. Thislumen may help to guide a guide wire or other elements of the deliverysystem. In some embodiments the pacing element or a portion of thepacing element may comprise a lumen. In some embodiments the implantablepacemaker may include a lumen.

In some embodiments the pacing element comprises an electrode. Thiselectrode may be disposed at any point along or on any portion of thedelivery system. In some embodiments the electrode may be disposedproximate the tip of the delivery system. In some embodiments thiselectrode may be disposed proximate the prosthetic heart valve disposedon the delivery system. In some embodiments this electrode may beconfigured to receive and transmit electric current. This electrode mayalso be configured to contact the heart and to provide pacing for someamount of time while the delivery system is present in the heart. Insome embodiments this electrode may be configured to pace the heartafter the delivery system has been removed from the heart.

Some embodiments disclose a method for providing a medical device andpacing a heart. This method may comprise introducing an assembly into aheart where the assembly may include a delivery system having a proximaland distal and. The assembly may also include an inner sheath and anouter sheath. The assembly may also include a biocompatible materialdisposed on some portion of the delivery system. In some embodimentsthis biocompatible material may be configured to collapse to a collapsedstate and be configured to expand to an expanded state. The assembly mayalso comprise a pacing element on some portion of the delivery system.The pacing element may be positioned proximate a tip region of thedelivery system.

The method may further include pacing the heart, retracting at least aportion of the delivery system, performing the procedure, and removingthe delivery system from the heart.

In some embodiments the procedure performed with the disclosed assemblyor apparatus may include a valve repair procedure or a prosthetic heartvalve implant procedure or another procedure. In some embodiments thismethod may include pacing the heart by contacting a pacing element suchas an electrode, to a wall of a heart ventricle. In some embodimentscontacting the pacing element to the ventricle may occur beforeexpanding a prosthesis, such as a prosthetic heart valve.

In some embodiments pacing the heart may begin or occur prior toremoving the delivery system from the heart. The method may alsocomprise attaching the pacing element to a portion of the heart. And insome embodiments this detached pacing element may be configured to pacethe heart after the delivery system is removed from the heart.

The pacing element may be disposed on part of a biocompatible material,such as a prosthesis. This prosthesis may be a prosthetic heart valve,such that the pacing element may be a strip of conductive materialattached to a portion of the prosthetic heart valve. The conductivematerial may also be integrally incorporated into the frame of theprosthesis. In such embodiments, the frame is molded or otherwise madesuch that the conductive material is incorporated into the frame. Insome embodiments the strip may be attached to the frame of theprosthetic heart valve. In some embodiments the prosthetic heart valvemay include multiple strips. These multiple strips may include one ormore conductive strips or one or more insulative strips or both. In someembodiments this conductive portion or portions of a prosthetic heartvalve may pace the heart. This pacing may occur during a procedure orafter the procedure has ended. In some embodiments the frame of theprosthetic heart valve comprises an insulated section or sections.

In some embodiments the prosthetic heart valve may comprise a coatingrather than a strip. This coating may function similarly to a strip inthat a conductive portion of prosthetic heart valve that is coated mayimprove pacing of a patient's heart.

The prosthetic heart valve may comprise a portion coated with aninsulative coating. The insulative coating may prevent interruption ofelectrical communication within the heart.

In some embodiments the disclosed assembly is configured to beintroduced into a heart. This assembly may comprise a delivery systemhaving a proximal and distal portion, a prosthetic heart valveconfigured to collapse and expand, and an implantable pacemaker. Thedelivery system may also comprise an inner sheath and an outer sheath.In some embodiments one or both of these sheaths is configured to beretractable. In some embodiments a prosthesis, such as a prostheticheart valve, is disposed on one of the sheaths in a collapsed state. Insome embodiments the prosthesis is disposed in one of the sheaths.

In some embodiments an implantable pacemaker is disposed on a portion ofthe delivery system, such as the distal portion. In some embodiments animplantable pacemaker is configured to electrically pace the heartduring and after a procedure on the heart. The implantable pacemaker maybe configured to contact or be attached to a ventricle of the heart.This implantable pacemaker may also be separated from the deliverysystem via an actuator.

In some embodiments the pacing element is configured to contact aportion of the heart. In some embodiments the pacing element isconfigured to be joined to portion of the heart. In some embodiments thepacing element is configured to be attached to a portion of the heart.

FIG. 1A shows an assembly in accordance with some embodiments. In someembodiments the delivery system comprises catheter 100. In someembodiments catheter 100 may comprise tip 110, capsule 120, inner sheath140, or outer sheath 130. In some embodiments catheter 100 may include apacing element 112, a lumen 114, attachment projection 116, barb 118,springs 117, or pins 115.

In some embodiments tip 110 may be disposed at the end of catheter 100.In some embodiments tip 110 may be proximate capsule 120. In someembodiments capsule 120 may be proximate inner sheath 140 or outersheath 130. In some embodiments one sheath may be proximate tip 110. Insome embodiments tip 110 may taper from a larger cross-sectional area toa smaller cross-sectional area. The tip may be a pointed tip, a blunttip, a cylindrical tip, or any other shape. In some embodiments theportion of the tip with a smaller cross-sectional area is disposeddistal the end of the tip adjacent capsule 120.

In some embodiments tip 110 comprises a pacing element 112. In someembodiments pacing element 112 is contained within tip 110. In someembodiments pacing element 112 is disposed on tip 110. In someembodiments pacing element 112 may be proximate the narrowed portion oftip 110.

In some embodiments a biocompatible material 200 is disposed in aportion of catheter 100. In some embodiments a biocompatible material200 is disposed on capsule 120 or another element of catheter 100. Insome embodiments a biocompatible material 200 is disposed in capsule120.

In some embodiments the biocompatible material 200 may comprise aprosthetic heart valve 300. The prosthetic heart valve 300 may comprisea valve assembly 310 and may comprise a frame 320. In some embodimentsthe frame 320 may comprise multiple portions. In some embodiments theframe 320 may comprise a conductive strip 322 or an insulative strip324. The frame 320 may alternatively comprise a conductive coatedportion 326 or an insulative coated portion 328. In some embodimentsprosthetic heart valve 300 may also comprise a control arm 330 and atleast one commissure post 340.

Referencing FIG. 1B, in some embodiments catheter 100 may comprise outersheath 130, inner sheath 140, capsule 120, and tip 110. In someembodiments tip 110 may comprise a pacing element 112. In someembodiments tip 110 may also comprise a lumen 114. This lumen may beconfigured so that one or multiple elements of catheter 100 may passthrough it. In some embodiments guide wire 400 may be able to passthrough the lumen 114. In some embodiments lumen 114 is in the center oftip 110. In some embodiments lumen 114 is not in the center of tip 110.

In some embodiments lumen 114 is concentric with a sheath of catheter100. This sheath may be either or both of inner sheath 140 or outersheath 130. In some embodiments lumen 114 may be wider than a guide wire400. In some embodiments tip 110 and the lumen 114 may be wider than asheath of catheter 100. In some embodiments the tip 100 and the lumen114 may be narrower than a sheath of catheter 100.

In some embodiments lumen 114 may tapered from a larger cross-sectionalarea to a smaller cross-sectional area. In some embodiments lumen 114may run the entire length of tip 110. Alternatively, the lumen may runonly a portion of the length of tip 110.

Now referring to FIG. 1C, in some embodiments the lumen 114 may not runthrough the center of tip 110. In some embodiments the lumen 114 may bedisposed on a portion of tip 110. In some embodiments lumen 114 may beconfigured to receive a sheath of catheter 100. In some embodimentscatheter 100 may include multiple lumens 114.

In some embodiments the multiple lumens are configured to receive aguide wire 400. In some embodiments the lumen 114 is configured to passa guide wire 400 through a side of a sheath of catheter 100. In someembodiments the sheath may be outer sheath 130 or inner sheath 140. Insome embodiments when guide wire 400 is fed through lumen 114, the guidewire 400 may pass through only a portion of the length of tip 100. Insome embodiments pacing element 112 may comprise a lumen 114. In someembodiments the guide wire 400 is configured to be passed through atleast a portion of pacing element 112 via a lumen 114.

In some embodiments tip 110 comprises a recess or cut out. In someembodiments this cut out will comprises a hole or an aperture. In someembodiments this cut out will permit guide wire 400 to be fed out to theside of tip 110, as shown in FIG. 1D. In some embodiments this cut outor recess may be rectangular shaped, triangular shaped, or circularshaped. In some embodiments the lumen 114 passes through the side of apacing element 112. In some embodiments the guide wire 400 is configuredto be passed through one or both of tip 110 and pacing element 112. Insome embodiments lumen 114 may create a sloped portion of tip 110 orpacing element 112, as shown in FIG. 1E. In some embodiments the lumen114 may be symmetric. In some embodiments the lumen 114 may beasymmetric.

In some embodiments pacing element 112 may comprise an implantablepacemaker. Alternatively pacing element 112 may comprise an electrode.The pacing element may have a power source disposed on catheter 100 ormay be connected to a power source not disposed on catheter 100. Thepower source may be outside the patient's heart 500.

In some embodiments pacing element 112 is configured to be detached fromcatheter 100. In some embodiments pacing element 112 is configured to bedetached from tip 110. In some embodiments pacing element 112 may beconfigured to pace the patient's heart 500 during a procedure. Thisprocedure may include a heart valve repair procedure, implanting aprosthetic heart valve, or another procedure on the heart.

In some embodiments the pacing element is configured to contact aportion of the patient's heart 500. The pacing element may be configuredto contact the ventricle 510, as shown in FIG. 2A. In some embodimentsthe pacing element 112 may be disposed at the narrowest point of tip110. In some embodiments pacing element 112 may be disposed on tip 110.The pacing element 112 may be disposed in tip 110.

In some embodiments tip 110 may further comprise an attachmentprojection 116. Tip 110 may also comprise multiple attachmentprojections 116. In some embodiments these attachment projections 116may be configured to deliver an electrical signal or stimulation to thepatient's heart 500 or specifically the ventricle 510. In someembodiments the attachment projections are configured to couple thepacing element 112 with the ventricle 510. In some embodimentsattachment projections 116 are configured to maintain contact of pacingelement 112 with patient's heart 500.

In some embodiments attachment projections 116 may be substantiallystraight. In some embodiments pacing attachment projections 116 may bemay comprise a straight and a curved portion. In some embodimentsattachment projections 116 may be curved. Attachment projections 116 maybe hook shaped.

In some embodiments pacing element 112 may comprise one, two, or moreattachment projections 116. In some embodiments attachment projections116 may extend away from tip 110. In some embodiments attachmentejections 116 may protrude from an end of tip 110. In some embodimentsthis will be a tapered or narrowed end of tip 110.

In some embodiments pacing element 112 may comprise an implantablepacemaker. This implantable pacemaker may comprise leads or it may beleadless. In some embodiments this implantable pacemaker may be smallenough to be disposed on a catheter-based delivery system. In someembodiments this pacemaker may be disposed in a ventricle of a patient'sheart. In some embodiments this pacemaker may be a percutaneous leadlesspacing system.

In some embodiments the pacing element 112 or tip 110 may contact theventricle 510 through a barb 118, as shown in FIG. 2B. In someembodiments these barbs 118 may be threaded along a portion thereof. Insome embodiments these barbs 118 may be coiled, wound, looped, twisted,or helical. In some embodiments these barbs 118 may be of varyinglengths. In some embodiments each of barbs 118 may be similar ordifferent in length. In some embodiments the diameter of the coils ofeach of the barbs 118 may be similar or different.

In some embodiments one barb 118 may include larger coils then anotherbarb 118. In some embodiments the barbs 118 may comprise threads. Insome embodiments barbs 118 may be configured to be advanced from tip 110into ventricle 510. In some embodiments barbs 118 may be configured tocontact a portion of a patient's heart 500. In some embodiments barbs118 may comprise multiple coils. In some embodiments barbs 118 maycomprise wire or other metal.

In some embodiments attachment projections 116 may comprise a metal,plastic, polymer, or a biocompatible material. In some embodimentsattachment projections 116 may comprise a coating. In some embodimentsthis coating may help prevent interruption of electrical communicationin patient's heart 500.

In some embodiments barbs 118 may extend more than half their lengthinto the ventricle 510. In some embodiments barbs 118 may only extend aportion of their length into ventricle 510.

In referring to FIG. 3A, in some embodiments catheter 100 may comprisean outer sheath 130, an inner sheath 140, a capsule 120, and tip 110. Insome embodiments tip 110 may comprise a pacing element 112. In someembodiments pacing element 112 may comprise a barb 118. In someembodiments barb 118 may extend from the center of tip 110 or pacingelement 112. In some embodiments barb 118 may extend from a taperedportion of tip 110. In some embodiments tip 110 may be configured to berotatable such that barb 118 may contact ventricle 510 of patient'sheart 500. In some embodiments actuating tip 110 or pacing element 112may result in barb 118 being advanced further into ventricle 510.Actuating barb 118 may also retract barb 118 from the ventricle 510. Insome embodiments rotating tip 110 or pacing element 112 may result inbarb 118 being advanced further into ventricle 510. Rotating barb 118 ina different direction may retract barb 118 from the ventricle 510.

In some embodiments barb 118 may comprise multiple coils or threads. Insome embodiments barb 118 is configured to advance out of tip 110. Thisprovides an advantage by being able to extend barb 118 when tip 110 isappropriately positioned. This also provides the advantage of preventinginjury to a patient while the catheter 100 is being advanced to adeployment site.

In referencing FIG. 3B catheter 100 may include outer sheath 130,capsule 120, and tip 110. In some embodiments tip 110 may comprise abarb 118 or an electrode 119. In some embodiments tip 110 may comprisemultiple electrodes 119. These electrodes may be configured to deliverelectrical signals to a portion of the patient's heart 500 orspecifically to a ventricle 510. In some embodiments these electrodesmay be configured to receive electrical signals from a power sourcedisposed on catheter 100. In some embodiments these electrodes may beconfigured to receive electrical signals from a power source connectedto catheter 100.

In some embodiments barb 118 may comprise an electrode 119 and barb 118may be configured to be advanced from a portion of catheter of tip 110.In some embodiments pacing element 112 may comprise barb 118 orelectrode 119. In some embodiments barb 118 can be threaded intoventricle 510 of patient's heart 500. In some embodiments a firstelectrode disposed on a barb 118 may be configured to provide a certainelectrical signal or output while a second electrode 119 may beconfigured to provide a different electrical signal or output.

In some embodiments attachment projection 116, barb 118, or electrode119 are configured to be advanced from tip 110 by actuating a separateportion of catheter 100. This actuation may come from a sheath 130outer, inner sheath 140, or another element of catheter 100 such as ahandle.

Referring to FIG. 3C, in some embodiments barb 118 may be configured tobe contained within tip 110 temporarily. In some embodiments barb 118may be configured to constrain a portion of catheter 100, such as outershaft 130. In some embodiments barb 118 may be disposed around outershaft 130. As shown in FIG. 3C, barb 118 may be configured to hold orconstrain outer sheath 130 such that outer sheath 130 cannot move. Barb118 may provide a mechanism to couple outer sheath 130 to tip 110.

In some embodiments barb 118 is configured to be in an undeployed stateand a deployed state. In some embodiments the undeployed state includesbarb 118 being as least partially contained within this tip 110. In someembodiments barb 118 can be advanced out of tip 110 from the undeployedstate to a deployed state. As shown in FIG. 3D, in the deployed statebarb 118 may at least partially not be contained by tip 110.

In some embodiments the barb 118 is configured to be advanced via outersheath 130, inner sheath 140, a handle of catheter 100, or capsule 120.In some embodiments barb 118 is advanced such that more than half of thelength of barb 118 resides outside of tip 110. In some embodiments barb118 is configured to be advanced from pacing element 112. In someembodiments barb 118 may comprise multiple coils.

In some embodiments some of the multiple coils of barb 118 may beconfigured to contact patient's heart 500, or more specifically aventricle 510. In some embodiments after barb 118 is in a deployedstate, a sheath of catheter 100 is less constrained. In some embodimentsafter barb 118 is in a deployed state the outer sheath 130 is configuredto be separated from tip 110 or capsule 120. In some embodiments afterbarb 118 is advanced, capsule 120 is configured to be retracted orseparated from tip 110.

Referring to FIG. 4A, in some embodiments pacing element 112 isconfigured to be an implantable pacemaker. In some embodiments catheter100 comprises a sheath, a tip 110, a pacing element 112, and attachmentprojections 116. As shown in FIG. 4A, catheter 100 may comprise athreaded sheath portion. In some embodiments tip 110 is configured to beadvanced into a patient's heart 500 or ventricle 510. In someembodiments the tip 110 comprises attachment projections 116 or anotherattachment means. In some embodiments attachment projections 116 preventtip 110 from separating from ventricle 510. In some embodiments whenattachment projections 116 are in contact with patient's heart,attachment projections 116 prevent rotation of tip 110 or pacing element112.

In some embodiments where catheter 100 comprises a threaded portion thisthreaded portion may be configured to be received by tip 110, as shownin FIG. 4A. In some embodiments the threaded portion of a sheath may beconfigured to be attached to tip 110 such that tip 110 is detachablefrom the threaded sheath of catheter 100. In some embodiments afterattachment projections 116 are advanced into the patient's heart 500,the tip 110 is configured to be held in place and prevent rotation. Insome embodiments after the pacing element 112 is positioned in theventricle 510, the threaded sheath of catheter 100 may be rotated. Thisrotation may permit the threaded sheath to be removed or separated fromthe tip 110. Thus tip 110 may be attached or detachable from the rest ofthe catheter 100 system and may remain attached to the patient's heart500. In some embodiments the multiple attachment projections 116 orother attachment means may provide the advantage of preventing rotationof the tip 110 while the sheath of catheter 100 is being rotated.

In some embodiments catheter 100 may comprise a tip 110, a capsule 120,an outer sheath 130, and an inner sheath 140. In some embodiments tip110 may further comprise springs 117 distal from the tapered portion oftip 110. In some embodiments springs 117 may be disposed adjacent outersheath 130. In some embodiments outer sheath 130 may comprise pins 115.In some embodiments pins 115 are configured to be positioned adjacentsprings 117. In some embodiments pins 115 prevent tip 110 from detachingfrom outer sheath 130. In some embodiments springs 117 actuate pins 115.In some embodiments inner sheath 140 prevents springs 115 from beingactuated by springs 117. In some embodiments the springs bias push pins115 inward toward inner sheath 140 or outer sheath 130, which may be atleast partially disposed within a portion of tip 110 or pacing element112.

In some embodiments inner sheath 140 is configured to be retracted. Wheninner sheath 140 is retracted pins 115 are configured to be actuated bysprings 117 such that tip 110 can be detached from or separated from asheath of catheter 100 such as outer sheath 130. In some embodimentsthis detachment of tip 110 and a sheath of catheter 100 may occur aftertip 110 or pacing element 112 is attached or contacted with a patient'sheart 500. In some embodiments tip 110 may only comprise one pin 115 andone spring 117. In some embodiments outer sheath 130 may only compriseone pin 115 and one spring 117. In other embodiments tip 110 or outersheath 130 may comprise multiple pins 115 or multiple springs 117.

In some embodiments an implantable pacemaker is configured to bedisposed on a portion of catheter 100. In some embodiments pacingelement 112 is configured to be an implantable pacemaker. Thisimplantable pacemaker may be configured to be an appropriate size to bedisposed on a catheter 100. This implantable pacemaker may be configuredso that it can be delivered by a catheter 100 through a blood vessel.

In some embodiments this implantable pacemaker will be appropriatelysized to fit the appropriate constraints of using a catheter-baseddelivery system. The implantable pacemaker may comprise a percutaneousleadless pacing system, a single chamber pacemaker, a dual chamberpacemaker, a biventricular pacemaker, or any other type. The implantablepacemaker may comprise zero, one, two, or more leads. The implantablepacemaker may comprise a power source or may be attached to a powersource separate from the pacemaker.

In accordance with some embodiments of the invention, as illustrated inFIG. 5, a pacing element 112 may be disposed on or be part of aprosthetic heart valve 300. In some embodiments the prosthetic heartvalve 300 may comprise a valve assembly 310, a frame 320, a control arm330, and at least one commissure post 340.

In some embodiments the valve assembly 310 may comprise multipleportions stitched or otherwise attached to each other. In someembodiments valve assembly 310 comprises bovine, porcine, biocompatible,or biological material. In some embodiments frame 320 comprises multipleelements. The frame 320 may constrain the valve assembly 310. In someembodiments the frame or a portion thereof may surround the valveassembly 310. In some embodiments the frame 320 or a portion thereof maybe surrounded by valve assembly 310. In some embodiments frame 320 mayfurther comprise attachment rings (not shown). In some embodiments frame320 may be made of a biocompatible material, such as a wire.

In some embodiments frame 320 may interact with a patient's heart 500such that the electrical communications of the patient's heart can beinterrupted. In some embodiments frame 320 is configured to prevent,alleviate, or correct some of these problems.

As illustrated in FIG. 5, in some embodiments frame 320 comprises aconductive strip 322. The frame 320 may comprise petals, sections,division, segments, or portions. A segment of frame 320 may comprise aconductive strip 322. In some embodiments the conductive strip mayextend from one end of one segment to the other end of the same segment.In some embodiments the conductive strip 322 surrounds a portion of theframe 322. In some embodiments the conductive strip extends from the endof the frame 320 distal the commissure post 340 to the other end offrame 320 proximate commissure post 340.

In some embodiments frame 320 may further comprise an insulative strip324. This insulative strip 324 may help prevent interference by theframe 320 with the patient's heart 500 after a prosthetic heart valve300 is placed in the patient. In some embodiments multiple portions offrame 320 may include insulative strips. Further, multiple portions offrame 320 may include conductive strips 322.

In some embodiments a conductive strip 322 may be may comprise onesegment of frame 320 while and insulative strip 324 may comprise asecond segment of frame 320. In some embodiments a conductive strip 322may be positioned adjacent an insulative strip 324. In some embodimentsframe 320 may comprise multiple conductive strips 322 and multipleinsulative strips 324. In some embodiments the multiple conductivestrips 322 and multiple insulative strips 324 may alternate or form apattern. In some embodiments the insulative strips 324 may be configuredto prevent the transmission of electrical energy to areas outside thetarget tissue or area. The insulative strips 324 may prevent unwantedinterference with the electrical communication of the heart.

The conductive strips 322 can provide multiple benefits to the patientwhile the prosthetic heart valve 300 is present in the patient. Theconductive strips 322 may correct pacing problems present before aprosthetic heart valve 300 was placed in the patient. The conductivestrips 322 may correct pacing problems resulting from a prosthetic heartvalve 300 being placed in the patient.

In some embodiments conductive strip 322 may create an additionalpathway to facilitate electrical communication in a patient's heart 500,as illustrated in FIG. 5. Thus the conductive strips may prevent orcorrect pacing problems within the patient's heart. In some embodimentsthe conductive strips may comprise a portion of frame 320 that contactsa patient's heart 500. In some embodiments the conductive strips 322 aredisposed on only a portion of a segment of frame 320.

As shown in FIG. 6, conductive strips 322 may be disposed on portions offrame 320. In some embodiments conductive strips 322 cover more than onesegment of frame 320. In some embodiments conductive strips 322 orinsulative strips 324 may be asymmetric. In some embodiments conductivestrips 322 may be a separate piece from frame 320.

In some embodiments conductive strip 322 extends and covers an openingbetween the wires of frame 320. In some embodiments conductive strips322 are wider than the wires or elements that otherwise comprise frame320, as shown in FIG. 6.

In some embodiments conductive strip 322 may taper to a point. In someembodiments the tapering of conductive strip 322 may follow the shape oroutline of a segment or portion of frame 320. In some embodimentsconductive strip 322 may extend from one end of a frame 322 to the otherend of frame 322, as shown in FIG. 6.

In some embodiments conductive strips 322 may be vertical or horizontal.These conductive strips may be of various shapes. The shapes ofconductive strips 322 may even vary on the same prosthetic heart valve300. In some embodiments the conductive strips 322 may cover only aportion of frame 320. While in other cases the conductive strips 322 maycover multiple portions or every portion of frame 320.

In some embodiments conductive strips 322 comprise highly conductivematerials. These conduct highly conductive materials may be any metal orother biocompatible material.

The same descriptions and characteristics described above regardingconductive strips 322 may also apply to the insulative strips 324.Similarly the same descriptions and characteristics described aboveregarding conductive strips 322 may also apply to the insulative strips324.

In some embodiments the insulative strips 324 may alternate with theconductive strips 322. In some embodiments frame 320 may comprise anasymmetric conductive strip 322 as well as an asymmetric insulativestrip 324. In some embodiments the total area of a conductive strip 322may be more or less than the total area of an insulative strip 324. Insome embodiments a conductive strip 322 may be configured tosubstantially contact a portion of a patient's heart 500, such as anative heart valve. In some embodiments conductive strips 322 may beconfigured to attach to a patient's heart 500. In some embodimentsconductive strips 322 may be joined to portions of frame 320 by anadhesive, a clamp, welding, or any other means.

In some embodiments the conductive strips 322 may be integral with frame320. In some embodiments the insulative strips 324 may be integral withframe 320. In some embodiments conductive strips 322 may be disposed onone side or area of frame 320, but not another side or area of frame320. In some embodiments conductive strips 322 comprise multipleportions of frame 320.

Referencing FIG. 7, in some embodiments conductive strips 322 orinsulative strips 324 may be configured to be rectangular shaped. Insome embodiments conductive strips 322 may be wider at the bottom thanthe top of the conductive strip. In some embodiments conductive strips322 may be any geometric shape, such as a rectangle. In some embodimentsconductive strips 322 may extend from one end of frame 320 towardanother end of frame 320. In some embodiments conductive strips 322 mayor may not extend the entire length of frame 320.

In some embodiments one conductive strip 322 may not directly contact ormay not be adjacent to another conductive strip 322. In some embodimentsa section of exposed frame 320 is adjacent to conductive strip 322 orinsulative strip 324. In some embodiments conductive strip 322 may beoriented to run vertically as shown in FIG. 7. In some embodiments frame320 has a distal and a proximal end, where the proximal end is proximatea commissure post 340. In some embodiments conductive strip 322 extendsfrom the distal end of frame 320 toward the proximal end of frame 320.

In some embodiments conductive strip 322 has a constant width. In someembodiments conductive strip 322 has a varying width. In someembodiments conductive strip 322 is narrower than a segment of frame320. In some embodiments conductive strip 322 is wider than a segment offrame 320. In some embodiments conductive strip 322 is wider thanmultiple segments of frame 320. In some embodiments conductive strip 322is disposed on top of frame 322 such that conductive strip 322 maycontact a patient's heart 500 when prosthetic heart valve 300 is placedin a patient.

As shown in FIG. 8, in some embodiments conductive strips 322 may bedisposed horizontally across frame 320. In some embodiments frame 320may comprise multiple conductive strips oriented in a horizontaldirection as shown in FIG. 8. In some embodiments the width of aconductive strip 322 may be less than or greater than the width of asegment of frame 320.

A conductive strip 322 may extend all the way around frame 320. In someembodiments conductive strip 322 may extend from the bottom or distalend of frame 320 to the end proximate a commissure. In thisconfiguration with a single conductive strip 322 extending the fulllength of frame 320, the conductive strip 322 may resemble a skirt.

In some embodiments conductive strip 322 is joined only at certainpoints along its length to frame 320. In some embodiments conductivestrip 322 is joined at every point along its length to frame 320.

In some embodiments an alternative to conductive strips 322 may be usedwith a prosthetic heart valve 300. In some embodiments a coating may beused. In some embodiments a conductive coating 326 may comprise aportion of frame 320. In some embodiments an insulative coating 328 maycomprise a portion of frame 320. In some embodiments a conductivecoating 326 or an insulative coating 328 may be applied to a segment offrame 320.

In some embodiments the portion of frame 320 comprising an conductivecoating 326 may be asymmetric. In some embodiments the portion of frame320 comprising an conductive coating 326 may be symmetric. In someembodiments the portion of frame 320 comprising an insulative coating328 may be asymmetric. In some embodiments the portion of frame 320comprising an insulative coating 328 may be symmetric.

In some embodiments a portion of frame 320 comprising a conductivecoating 326 is adjacent to another portion of frame 320 comprising aninsulative coating 328. Multiple portions of frame 320 may comprise aconductive coating 326. Similarly, multiple portions of frame 320 maycomprise an insulative coating 328. In some embodiments frame 320 maycomprise alternating conductive coating 326 portions and insulativecoating 328 portions.

In some embodiments conductive coating 326 may be applied to the entirelength of frame 320. In some embodiments conductive coating 326 may beapplied only to a portion of the total length of frame 320.

Referring now to FIG. 9, in some embodiments the surface area of frame320 that comprises a conductive coating 326 may be the same surface areaof frame 320 that comprises an insulative coating 328. In someembodiments the conductive coating 326 may be applied to at least aportion of frame 320 that contacts a patient's heart 500. In someembodiments the conductive coating 326 may be applied to the frame 320after the valve assembly 310 and frame 320 are coupled together. In someembodiments the conductive coating 326 may be applied to the frame 320before the valve assembly 310 and frame 320 are coupled together.

In some embodiments the conductive coating 326 helps prevent or correctabnormal electrical communication in a patient's heart 500. In someembodiments the conductive coating helps facilitate communication in thepatient's heart 500.

The foregoing description has been presented for purposes ofillustration and description. It is not intended to be exhaustive or tolimit the precise embodiments disclosed. Any discussion related to oneelement disclosed may also apply with equal force to any other element.Other modifications and variations may be possible in light of the aboveteachings. The embodiments and examples were chosen and described inorder to best explain the principles of the embodiments and theirpractical application, and to thereby enable others skilled in the artto best utilize the various embodiments with modifications as are suitedto the particular use contemplated. By applying knowledge within theskill of the art, others can readily modify and/or adapt for variousapplications such specific embodiments, without undue experimentation,without departing from the general concept. Therefore, such adaptationsand modifications are intended to be within the meaning and range ofequivalents of the disclosed embodiments, based on the teaching andguidance presented herein.

What is claimed is:
 1. A medical device delivery assembly, the assemblycomprising: a catheter-based delivery system having an electrical pacingelement at a tip region of the catheter-based delivery system; whereinthe delivery system is configured to receive a biocompatible material.2. The assembly of claim 1, wherein the biocompatible material comprisesa prosthesis.
 3. The assembly of claim 2, wherein the prosthesiscomprises a prosthetic heart valve, and wherein the pacing elementcomprises an implantable pacemaker.
 4. The assembly of claim 3, whereinthe implantable pacemaker is configured to pace the heart during aprocedure to implant the prosthetic heart valve, and wherein theimplantable pacemaker is configured to contact a ventricle of the heart.5. The assembly of claim 4, wherein the implantable pacemaker isconfigured to pace the heart after a procedure to implant the prostheticheart valve.
 6. The assembly of claim 1, wherein the electrical pacingelement is configured to pace the heart during a heart valve repairprocedure.
 7. The assembly of claim 1, wherein the catheter-baseddelivery system further comprises a lumen, and wherein the pacingelement is configured to permit a delivery system element to pass thruthe pacing element.
 8. The assembly of claim 2, wherein the pacingelement comprises an electrode disposed proximate an end of the deliverysystem, wherein the electrode is configured to receive and transmitelectric current and contact the heart to provide pacing for at least aportion of time when the delivery system is present in the heart.
 9. Amethod for providing a medical device and pacing a heart, the methodcomprising: introducing an assembly into a heart, the assemblycomprising: a delivery system having proximal and distal ends andincluding an inner sheath and an outer sheath, a biocompatible materialdisposed the inner sheath in a collapsed state and configured to expandto an expanded state, a pacing element positioned proximate a tip regionof the delivery system, pacing the heart, retracting the outer sheath,implanting the biocompatible material, and removing the delivery systemfrom the heart.
 10. The method of claim 9, wherein the biocompatiblematerial comprises a prosthetic heart valve, wherein pacing the heartcomprises contacting a pacing element including an electrode to a wallof a ventricle before expanding the heart valve and providing electricalcurrent to the electrode, and wherein pacing the heart ends prior toremoving the delivery system from the heart.
 11. The method of claim 9,further comprising detaching the pacing element from the assembly andcontacting the pacing element to a ventricle of the heart, whereinpacing the heart occurs after removing the delivery system from theheart.
 12. The method of claim 9, wherein the prosthetic heart valvefurther comprises a valve assembly and a frame, wherein pacing the heartcomprises using the prosthetic heart valve with a conductive portion ofthe frame such that the conductive portion paces the heart.
 13. Themethod of claim 9, wherein the prosthetic heart valve further comprisesa valve assembly and a frame, wherein pacing the heart comprises usingthe prosthetic heart valve with conductive portions of the frame suchthat the conductive portions pace the heart.
 14. The method of claim 13,wherein the prosthetic heart valve further comprises an insulativeportion of the frame.
 15. The method of claim 9, wherein pacing theheart further comprises contacting an implantable pacemaker to aventricle and providing electrical current to the heart via theimplantable pacemaker, and wherein pacing the heart continues afterremoving the delivery system from the heart.
 16. The assembly of claim9, wherein the heart valve comprises a valve assembly and a frame and apacing strip.
 17. The assembly of claim 16, wherein the pacing stripcomprises a conductive section attached to the frame of the heart valveto improve electrical communication in the heart.
 18. The assembly ofclaim 17 wherein the frame of the heart valve further comprises aninsulated section to impede electrical communication in the heart. 19.The assembly of claim 18, wherein the frame of the heart valve furthercomprises multiple insulated sections or multiple conductive sections.20. An assembly for introduction into a heart, the assembly comprising:a delivery system having proximal and distal portions; a heart valveconfigured to collapse and expand; and an implantable pacemaker; whereinthe delivery system comprises an inner sheath and an outer sheath;wherein the inner sheath and outer sheath are configured to beretractable, wherein the heart valve is disposed on the inner sheath ina collapsed state, wherein the implantable pacemaker is disposed on thedistal portion of the delivery system, wherein the implantable pacemakeris configured to electrically pace the heart during and afterimplantation of the heart valve, wherein the implantable pacemaker isconfigured to contact a ventricle of a heart and separate from thedelivery system.